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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076763

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NDA 076763 describes CLOTRIMAZOLE, which is a drug marketed by Fougera Pharms, Glenmark Pharms, Taro, Actavis Mid Atlantic, Teva, Paddock Llc, and West-ward Pharms Int, and is included in fifteen NDAs. It is available from eighteen suppliers. Additional details are available on the CLOTRIMAZOLE profile page.

The generic ingredient in CLOTRIMAZOLE is betamethasone dipropionate; clotrimazole. There are sixty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.
Summary for 076763
Tradename:CLOTRIMAZOLE
Applicant:Paddock Llc
Ingredient:clotrimazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 076763
Ingredient-typeAzoles
Medical Subject Heading (MeSH) Categories for 076763
Suppliers and Packaging for NDA: 076763
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOTRIMAZOLE clotrimazole TROCHE/LOZENGE;ORAL 076763 ANDA Paddock Laboratories, LLC 0574-0107 N 0574-0107-14
CLOTRIMAZOLE clotrimazole TROCHE/LOZENGE;ORAL 076763 ANDA Paddock Laboratories, LLC 0574-0107 N 0574-0107-70

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TROCHE/LOZENGE;ORALStrength10MG
Approval Date:Oct 28, 2005TE:ABRLD:No

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